Durasoft(R) 3 for Ext Wear

FDA premarket approval P830037 · Lenses, soft contact, extended wear

PMA numberP830037

Approval

Applicant
Alcon Laboratories, Inc.
Received
July 7, 1983
Decision date
April 24, 1984 (APWD)
Supplements
50, latest November 8, 2012
Product code
LPM – Lenses, Soft Contact, Extended Wear

Official FDA PMA record

Approval order statement

APPROVAL FOR THE DURASOFT 3 (PHEMFILCON A) EXTENDED WEAR HYDROPHILIC CONTACT LENS. THE LENS IS INDICATED FOR UP TO 14 DAYS OF CONTINUOUS WEAR BETWEEN CLEANING AND DISINFECTION (EXTENDED WEAR) BY PERSONS WITH EYES THAT ARE NON-DISEASED, NOT-APHAKIC, HAVE NO MORE THAN 2.00 DIOPTERS (D) OF ASTIGMATISM, AND REQUIRE A SPHERICAL LENS IN THE POWER RANGE FROM -20.00 D TO +0.00 D FOR THE CORRECTION OF NEARSIGHTEDNESS (MYOPIA) OR FARSIGHTEDNESS (HYPEROPIA). THE LENS IS TO BE DISINFECTED USING EITHER A HEAT (THERMAL) OR A CHEMICAL (NOT HEAT) DISINFECTION SYSTEM.